Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Lung Cancer Clinical Trial

Official title:

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648178
• Other study ID #: D15154
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test feasibility, in smokers with lung, head & neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.

Description:

The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histological or cytological diagnosis of lung, head & neck, or bladder cancer within the past 5 years.

2. AJCC (American Joint Committee on Cancer) stages I-IV

3. Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm

4. Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program)

5. May be receiving anti-cancer agents

6. Age 18 or older

7. Fluent in English;

8. Patient must be capable and willing to provide informed written consent for study participation;

9. Able to participate in study visits

Exclusion Criteria:

1. Cancer surgery planned in the next 9 weeks;

2. Treatment with radiation planned for the next 9 weeks,

3. Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.)

4. Any use of e-cigarettes in the past 30 days,

5. Pregnant or trying to get pregnant.

Related Conditions & MeSH terms

• Bladder Cancer
• Cancer of Head and Neck
• Head and Neck Neoplasms
• Lung Cancer
• Nicotine Dependence, Other Tobacco Product
• Tobacco Use Disorder

Intervention

Device:
• HALO
HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day	Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.	12 Weeks
Primary	Average Number of E-cigarettes Used Per Day	Average number of e-cigarettes used per day over the 12 week period	12 Weeks